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Company Name Brand Name GMDN Term Name GMDN Term Status FDA Product Code Name FDA Product Code Device Packaged As Sterile Sterilization Prior To Use Issuing Agency Device Size Type Device Class Implantable

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Atoll™ - 10889981052515

4.0mm x 16mm Poly Screw Assm. The Atoll OCT Spinal System is intended for use as an aid in spine fusion. It consists of screws, hooks, rods, and connectors. These components are available in a variety of sizes to allow for a variety of configurations to better fit each individual patient's pathology. The Atoll OCT Spinal System components are manufactured from medical implant grade titanium alloy Ti-6Al-4V (ELI) per ASTM F-136 or ISO 5832-3.
SEASPINE ORTHOPEDICS CORPORATION
16-12-4016
In Commercial Distribution

  • 10889981052515 ()

  • 4.0mm x 16mm
16-12-4016

  • Bone-screw internal spinal fixation system, non-sterile

Atoll™ - 10889981052508

4.0mm x 14mm Poly Screw Assm. The Atoll OCT Spinal System is intended for use as an aid in spine fusion. It consists of screws, hooks, rods, and connectors. These components are available in a variety of sizes to allow for a variety of configurations to better fit each individual patient's pathology. The Atoll OCT Spinal System components are manufactured from medical implant grade titanium alloy Ti-6Al-4V (ELI) per ASTM F-136 or ISO 5832-3.
SEASPINE ORTHOPEDICS CORPORATION
16-12-4014
In Commercial Distribution

  • 10889981052508 ()

  • 4.0mm x 14mm
16-12-4014

  • Bone-screw internal spinal fixation system, non-sterile

Atoll™ - 10889981052492

4.0mm x 12mm Poly Screw Assm. The Atoll OCT Spinal System is intended for use as an aid in spine fusion. It consists of screws, hooks, rods, and connectors. These components are available in a variety of sizes to allow for a variety of configurations to better fit each individual patient's pathology. The Atoll OCT Spinal System components are manufactured from medical implant grade titanium alloy Ti-6Al-4V (ELI) per ASTM F-136 or ISO 5832-3.
SEASPINE ORTHOPEDICS CORPORATION
16-12-4012
In Commercial Distribution

  • 10889981052492 ()

  • 4.0mm x 12mm
16-12-4012

  • Bone-screw internal spinal fixation system, non-sterile

Atoll™ - 10889981052485

4.0mm x 10mm Poly Screw Assm. The Atoll OCT Spinal System is intended for use as an aid in spine fusion. It consists of screws, hooks, rods, and connectors. These components are available in a variety of sizes to allow for a variety of configurations to better fit each individual patient's pathology. The Atoll OCT Spinal System components are manufactured from medical implant grade titanium alloy Ti-6Al-4V (ELI) per ASTM F-136 or ISO 5832-3.
SEASPINE ORTHOPEDICS CORPORATION
16-12-4010
In Commercial Distribution

  • 10889981052485 ()

  • 4.0mm x 10mm
16-12-4010

  • Bone-screw internal spinal fixation system, non-sterile

Atoll™ - 10889981052478

4.0mm x 8mm Poly Screw Assm. The Atoll OCT Spinal System is intended for use as an aid in spine fusion. It consists of screws, hooks, rods, and connectors. These components are available in a variety of sizes to allow for a variety of configurations to better fit each individual patient's pathology. The Atoll OCT Spinal System components are manufactured from medical implant grade titanium alloy Ti-6Al-4V (ELI) per ASTM F-136 or ISO 5832-3.
SEASPINE ORTHOPEDICS CORPORATION
16-12-4008
In Commercial Distribution

  • 10889981052478 ()

  • 4.0mm x 8mm
16-12-4008

  • Bone-screw internal spinal fixation system, non-sterile

Atoll™ - 10889981052461

3.5mm x 50mm Poly Screw Assm. The Atoll OCT Spinal System is intended for use as an aid in spine fusion. It consists of screws, hooks, rods, and connectors. These components are available in a variety of sizes to allow for a variety of configurations to better fit each individual patient's pathology. The Atoll OCT Spinal System components are manufactured from medical implant grade titanium alloy Ti-6Al-4V (ELI) per ASTM F-136 or ISO 5832-3.
SEASPINE ORTHOPEDICS CORPORATION
16-12-3550
In Commercial Distribution

  • 10889981052461 ()

  • 3.5mm x 50mm
16-12-3550

  • Bone-screw internal spinal fixation system, non-sterile

Atoll™ - 10889981052454

3.5mm x 45mm Poly Screw Assm. The Atoll OCT Spinal System is intended for use as an aid in spine fusion. It consists of screws, hooks, rods, and connectors. These components are available in a variety of sizes to allow for a variety of configurations to better fit each individual patient's pathology. The Atoll OCT Spinal System components are manufactured from medical implant grade titanium alloy Ti-6Al-4V (ELI) per ASTM F-136 or ISO 5832-3.
SEASPINE ORTHOPEDICS CORPORATION
16-12-3545
In Commercial Distribution

  • 10889981052454 ()

  • 3.5mm x 45mm
16-12-3545

  • Bone-screw internal spinal fixation system, non-sterile

UCR - 10889981036201

PEDICLE 9.0 X 5.0 MM
SEASPINE ORTHOPEDICS CORPORATION
14-9050
In Commercial Distribution

  • 10889981036201 ()

  • 9.0 X 5.0 MM
14-9050

  • Bone-screw internal spinal fixation system, non-sterile

UCR - 10889981036195

LAMINAR 7.0 X 8.0 MM
SEASPINE ORTHOPEDICS CORPORATION
14-7080
In Commercial Distribution

  • 10889981036195 ()

  • 7.0 X 8.0 MM
14-7080

  • Bone-screw internal spinal fixation system, non-sterile

UCR - 10889981036188

LAMINAR 7.0 X 6.5 MM
SEASPINE ORTHOPEDICS CORPORATION
14-7065
In Commercial Distribution

  • 10889981036188 ()

  • 7.0 X 6.5 MM
14-7065

  • Bone-screw internal spinal fixation system, non-sterile
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